Thrombocytopenia prevention

Adverse reactions-

Cardiovascular -           atrial fibrillation/flutter   1%     palpitations  3%      syncope 6%
                                        tachycardia   3%                      vasodilation 9%

CNS-                              dizziness  28%       headache  36%     insomnia 27%

Dermatologic-              rash   16%

GI -                                diarrhea  33%     mucosistis  37%   nausea/vomiting  70%
                                      oral monoliasis  1%

Respiratory -                 cough increased  22%     dyspnea   22%   pharyngitis    16%
                                        pleural effusion 0%           rhinitis  31%

Special senses-            conjuntivial injection  3%

Miscellaneous-              edema  15%         fever   28%     neutropenic fever  42%
    

Hypersensitivity to any of the components or the product

Special precautions-

Myeloblastic chemotherapy-  oprelverkin is not indicated following myleblstic chemotherapy.
In phase 2 clinical studies  significantly increased incidence in edema, conjuntivial bleeding,
hypotension, and tachycardia was observed in patients receiving oprelvenkin as compared to
placebo.

Fluid retention- use with caution in patients with clinically evident congestive heart failure, patients
receiving aggresive hydration,patients who are susceptible to developing congestive heart
failure, patients with a history of heart failure who are well compensated and receiving appropiate
medical therapy and patients who may develop fluid retention as a result of associated medical
conditions or whose conditions may be excaberted by fluid retention.

Cardiovascular effects-oprelvenkin use is associated withcardiovascular reactions.
Use with caution in patients with a history of artial arrhythmias, and only after consideration  of the
potential risks in relation to the anticipated benefit

CNS effects- stroke has been reported in the setting of patients who develop fibrillation/ flutter
while receiving oprelvekin. Patients with a history of stroke or ischemic attack may be at increased
risk of these reactions.

Papilledema - changes in visual  acutity and or/ visual field defects ranging from blurred vision
to blindness can occur in patients with papilledema taking opevelkin.

Hypersensitivity reactions- such as, edema of the face, tongue, or larynx, shortness of breath,
 wheezing, chest pain, hypotension, including shock, dysarthias, loss of consciousness,
 mental status changes rash, urticaria, fushing fever, have occured.
If hypersensitivity reactions occur,seek medical attentions

Renal function impairment- fluid retention associated with oprelvekin treatment have not been
studied in patients with renal function impairment, but carefully monitor fluid balance in these
 patients

Pregnancy- use operlvekin during pregnancy only if the potential benefit justifies the potential
risk to the fetus.

Lactation- decide whether to discontinue breast feeding or the drug depending   on the importance
of the drug to the mother.

Children- a safe and effective dose of oprelvekin has not been established in children.

Monitoring- obtain a complete blood cell count prior to chemotherapy and at regular intervals
during  operlvekin therapy. Monitor platelet counts

Indication-
Thrombocytopenia prevention

Dosage-
20mgmcg/kg given once daily

Initiate dosing 6 to 24 hours after the completion of chemotherapy.
Monitor platelet counts periodically to ascess the optimal duration of therapy

1. Use oprelvekin under the guidelines and supervision of a heath care provider.

2. Inform patients of the most serious and common adverse reactions  associated with oprelvekin.
    administration, including those symptoms related to allergic and hypersensitivity reactions

3. Advice patients who have preexisting pleural or other effusions or a history of congestive
   heart failure to contact their health care provider for worsening of dyspnea.

4. Most patients  who receive oprevelkin  develop anemia. Advice patients to contact their
   healthcare provider if symptoms attributable to atrial arrhythmias, develop.

Pharmacology-
The primary hematopoietic activity of operlvikin is stimulation of megakaryotopoiesis
and thrombopoiesis.

Pregnancy-
Use operlvekin during pregnancy only if the potential benefit justifies the potential
risk to the fetus.

Lactation-
Decide whether to discontinue breast feeding or the drug depending   on the importance
of the drug to the mother.

Children-
A safe and effective dose of oprelvekin has not been established in children.